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WO2009142918A2 - Dispositif et procédé d'échantillonnage de biopsie par mesure d'une impédance électrique - Google Patents

Dispositif et procédé d'échantillonnage de biopsie par mesure d'une impédance électrique Download PDF

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Publication number
WO2009142918A2
WO2009142918A2 PCT/US2009/043181 US2009043181W WO2009142918A2 WO 2009142918 A2 WO2009142918 A2 WO 2009142918A2 US 2009043181 W US2009043181 W US 2009043181W WO 2009142918 A2 WO2009142918 A2 WO 2009142918A2
Authority
WO
WIPO (PCT)
Prior art keywords
impedance
sampling device
biopsy
trocar
outer needle
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US2009/043181
Other languages
English (en)
Other versions
WO2009142918A8 (fr
WO2009142918A3 (fr
Inventor
Ryan Joseph Halter
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Dartmouth College
Original Assignee
Dartmouth College
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Dartmouth College filed Critical Dartmouth College
Priority to US12/994,055 priority Critical patent/US20110105948A1/en
Publication of WO2009142918A2 publication Critical patent/WO2009142918A2/fr
Publication of WO2009142918A3 publication Critical patent/WO2009142918A3/fr
Publication of WO2009142918A8 publication Critical patent/WO2009142918A8/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/05Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves
    • A61B5/053Measuring electrical impedance or conductance of a portion of the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
    • A61B10/02Instruments for taking cell samples or for biopsy
    • A61B10/0233Pointed or sharp biopsy instruments
    • A61B10/0266Pointed or sharp biopsy instruments means for severing sample
    • A61B10/0275Pointed or sharp biopsy instruments means for severing sample with sample notch, e.g. on the side of inner stylet
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/05Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves
    • A61B5/053Measuring electrical impedance or conductance of a portion of the body
    • A61B5/0538Measuring electrical impedance or conductance of a portion of the body invasively, e.g. using a catheter
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B2017/00017Electrical control of surgical instruments
    • A61B2017/00022Sensing or detecting at the treatment site
    • A61B2017/00026Conductivity or impedance, e.g. of tissue

Definitions

  • the present apparatus relates to the field of tissue sampling devices for obtaining specimens of tissue for pathological examination, and to the field of medical instrumentation devices.
  • Samples are often taken from inclusions using a sampling device having an outer tube and an inner probe or needle having a cutting cavity on a side.
  • the device is inserted into the inclusion and the inner probe or needle is operated to capture a small piece of tissue from the inclusion in the cavity.
  • the device is removed and the sample analyzed.
  • a problem when taking samples of inclusions, especially smaller inclusions, in tissues is that it can be difficult to ensure that the sample is taken of the inclusion and not of adjacent, likely healthy, tissue. When normal, nearby, tissue is sampled instead of the inclusion, pathological analysis of the sample will not give a correct diagnosis and may give sufficiently misleading information that no or inappropriate treatment is provided to patients instead of appropriate curative treatment.
  • imaging-guided biopsy techniques may be used.
  • Computed Tomography (CT) - guided biopsy techniques are often used with some organs. These techniques require taking multiple images of a patient to observe both the inclusion and a sampling device; the images are taken at intervals during the process of inserting and manipulating the sampling device into the inclusion.
  • CT- guided biopsy techniques pose issues with high radiation dose from multiple CT images, and do not always provide good resolution of the inclusions especially when the inclusions are in low density tissues surrounded by high density tissues. Further, CT machines are somewhat bulky and moderately expensive.
  • WO/2002/085216 describes a biopsy sampling device adapted for Magnetic Resonance Imaging (MRI)-guided biopsies.
  • This device has an outer shield and an inner probe, where the inner probe is electrically insulated from the outer shield by an insulation layer on the inner conductor.
  • This device serves as a radio- frequency antenna to sense resonance during operation of an MRI system, requiring an expensive MRI machine during taking of a biopsy sample.
  • it since it is intended for use within the intense magnetic field of an MRI system, it must be made of non-ferrous exotic materials such as gold that are not affected by, and do not affect, the magnetic field of the MRI machine.
  • This device is used to sample an organ while imaging the organ, so that samples may be obtained from particular suspicious inclusions within the organ.
  • a biopsy sampling device has an inner trocar having a sharpened tip and a sampling opening.
  • the trocar is slideably engaged in a central cavity of an outer needle with its sharpened tip and sampling opening protruding from an end of the outer needle.
  • Electrical impedance measuring apparatus measures electrical impedance between the inner trocar and the outer needle.
  • the inner trocar has an insulating coating over those portions of the inner trocar that are located within the central cavity of the outer needle.
  • impedance measurements are made at multiple frequencies and spectral parameters are obtained from the measurements.
  • the sampling device is used to obtain samples from an organ at points in the organ where impedance differs from an impedance of normal or surrounding organ tissue.
  • the sampling device is used to obtain impedance measurements from an organ at points in the organ where biopsy samples are taken, these are points where impedance has potential to differ from normal or surrounding organ tissue.
  • the impedance measurements are used together with pathological analysis of the samples to formulate a diagnosis and treatment plan.
  • FIG. 1 is a sectional diagram of a tip of a biopsy sampling device.
  • FIG. 2 is a block diagram of a biopsy sampling device.
  • FIG. 3 is a flow chart of one method of operating the sampling device wherein the device is used to obtain impedance information at sample points within an organ.
  • FIG. 4 is a flow chart of a method of operating the sampling device wherein the device is used to guide acquisition of samples while advancing the sampling device to desired sample locations.
  • adenocarcinoma malignant tumors of the prostate were found to have electrical conductivity and permittivity (components of electrical impedance) that differed from tissues associated with benign prostate hypertrophy or normal prostate stroma at frequencies of greater than 92 KHz.
  • prostatic tissues I. Single frequency admittivity properties, accepted for publication sometime in 2009 in Journal of Urology has also been done. In this study of tissue samples of adenocarcinoma, benign prostatic hyperplasia, non- hyperplastic glandular tissue, and stroma samples taken from radical prostatectomy specimens from 50 men, it was shown that, in addition to significant conductivity differences between malignant and benign prostate tissue, there are significant permittivity differences. The direction and magnitude of these differences changes depending on the frequency at which the electrical properties were gauged. In particular, the permittivity of prostate cancer at 100 kHz is twice that of benign prostatic hyperplasia, non-hyperplastic glandular tissue, and normal prostatic stroma. When permittivity at 100 kHz was used to discriminate cancer from benign tissues it provided a specificity of 77% at a sensitivity level of 70%.
  • the electrical properties of tissue are a function of the AC frequency at which they are sampled. This frequency dependence is also a function of tissue morphology and this spectral dependence has the potential to provide enhanced clinical utility.
  • the electrical properties were sampled at 31 logarithmically spaced frequencies ranging from 100 Hz to 100 kHz.
  • Four multi-frequency based spectral parameters defining the recorded spectrum ( ⁇ ⁇ , ⁇ , f c , and ⁇ ) using a Cole-type model were extracted from each of the electrical property spectra.
  • the Cole-type model is similar to that described in Cole KS and Cole RH, Dispersion and absorption in dielectrics: I. Alternating current characteristics J Chem Phys, 9: 341-351, 1941.
  • These spectral parameters are typically thought to represent: 1) ⁇ ⁇ , (extrapolated impedance at infinite frequency): a measure of cumulative intra- and extra-cellular fluid conductivity
  • (a measure of a broadness of the spectra): a measure of tissue heterogeneity
  • a biopsy sampling device 100 (FIGs. 1 and 2) has a central sampling needle trocar 102, which may have a single-tapered (as shown in FIG.
  • the central sampling needle trocar 102 has an electrically insulating, biocompatible, coating 104 adherent thereto, such as Epoxylite ® 6000 M.
  • Epoxylite is a trademark of Elantus PDG Inc, St Lois, MO, a subsidiary of Elantas of Wessel, Germany.
  • outer hollow needle 106 is an 18-gauge needle.
  • outer hollow needle 106 is coated with an outer-needle insulating, biocompatible, coating 108 adherent thereto; in an embodiment this is formed of the same Epoxylite 6000 M material used for the coating on the sampling needle trocar 102.
  • the uninsulated tip portion of the outer needle has length about two millimeters.
  • insulating coating 104 is less than fifty microns thick so that the central sampling needle trocar 102 of about ninety-nine hundredths inch diameter can freely slide within the outer hollow needle 106.
  • the sampling device 100 need not be used in a magnetic resonance imaging environment, in an embodiment the central sampling needle trocar 102 and outer hollow needle 106 are made of ferrous metal, such as stainless steel as known in the surgical instrument art.
  • Central sampling needle trocar 102 has a sample slot 110 cut into it.
  • tissue possibly including a portion of an inclusion - enters the sample slot 110.
  • the sampling needle trocar 102 may then be withdrawn through the outer needle 106 and a cutting edge 112 separates a sample of the tissue from the tissue.
  • the sample may be placed in a pathology sample container (not shown) and the sampling needle trocar 102 reinserted into the outer needle 106 to obtain additional samples.
  • Outer hollow needle 106 is fitted with a manipulation handle 120, which is adapted with mechanical keying apparatus such that, in embodiments like that of FIG. 2 with a single-tapered tip, sampling needle trocar 102 is not free to rotate with respect to outer hollow needle 106.
  • Four wires are brought out to a connector 122 from the needles 102, 106, two attached to the sampling needle trocar 102 and two to the outer needle 106.
  • One wire attached to sampling needle trocar 102 is coupled through connector 122 to a stimulus circuit of impedance measuring system 124, the other wire connected to sampling needle trocar 102 is coupled to a measurement circuit of impedance measuring system 124.
  • one wire attached to outer needle 106 is coupled through connector 122 to a stimulus circuit of impedance measuring system 124, the other wire connected to outer needle 106 is coupled to a measurement circuit of impedance measuring system 124 having display and recording apparatus 128.
  • more subject to interference by dirty or loose connections only two electrical connections are used, one to the trocar 102 and one to the outer needle 106.
  • the manipulation handle 120 is also fitted with an impedance test button 126 to trigger measurement and acquisition of electrical impedance data.
  • the tip of the sampling device is advanced 302 into the prostate, or into another organ of the subject that is suspected of having an inclusion requiring biopsy, to a point at which it is desired to obtain a sample.
  • Guidance of the sampling device may be according to a predetermined pattern or according to images obtained from a separate imaging modality.
  • impedance test button 126 is pressed; at this time high frequency impedance characteristics of the tissue are measured 304 by applying a low current, high frequency, stimulus current having at least one, and in an embodiment several, frequencies between 100 Hz and 1 MHz by stimulus circuits of the impedance measuring system 124, and measuring voltages developed between the needles with the measurement circuit of impedance measuring system 124, these measurements are recorded.
  • impedance measurements may also be taken between either needle 106 or trocar 102 and the external electrode 130.
  • the trocar 102 is reinserted 308 and the sampling device tip advanced further or otherwise repositioned to obtain additional samples; as an example additional samples might be collected following a predetermined, 12-point, pattern as is often used for prostate biopsy.
  • the measured pattern of conductivity, permittivity, and spectral parameters, measured within the organ is compared 312 to patterns of conductivity, permittivity, and spectral parameters of both normal and diseased organs.
  • Pathological examination of samples is also performed 314. Both information from the pattern of impedance and spectral parameters, and from the pathological examinations are used to establish 316 a diagnosis and treatment plan.
  • the impedance and spectral parameter measurements give additional information about tissue characteristics surrounding an analyzed sample that is useful for diagnosis 316, and in particular useful for estimating tumor size and aggressiveness.
  • tumor staging in turn is of great interest in devising a treatment plan.
  • large rapidly growing tumors may require radical prostatectomy, while smaller tumors are more likely to be treated by less invasive techniques such as transurethral resection or active surveillance.
  • impedance changes are used to guide sampling while advancing the sampling device into an organ 302 (FIG. 3) along a path guided by other imaging modalities towards an inclusion or a path otherwise aimed towards a desired sample location.
  • the impedance characteristics of the tissue are monitored 404 by applying a high frequency stimulus current from the stimulus circuits of the impedance measuring system 124 and measuring voltages developed between the needle 106 and trocar 102, or in an alternative embodiment between trocar 102 and external electrode 130, with the measurement circuit of impedance measuring system 124, the measurements are averaged and filtered over a short period of time to avoid artifacts, the spectral parameters are extracted, and selected measurements are displayed to a operator.
  • the operator When the operator sees a change of impedance in a suspect direction, such as an increase of impedance 406, indicating a suspect inclusion is within a few millimeters of the tip of the sampling device 100, the operator advances 408 the sampling device 100 a predetermined distance of a few millimeters until the suspect inclusion is expected to be nearest to the sample slot 110.
  • the sampling device is positioned within the area of suspect impedance, impedance is measured 409 and recorded, and the center trocar 102 of the sampling device is then withdrawn 410 to obtain a biopsy sample of the suspected inclusion.
  • the center trocar 102 is reinserted 412 into the sampling device and advancement sampling device is then continued towards other locations, such as predetermined locations or locations guided by other imaging methods, within the organ from which samples are to be taken.
  • both samples according to predetermined locations in the organ and samples according to impedance changes may be taken and submitted for pathological analysis for diagnostic purposes.
  • Information from pathological analysis of the samples, and information from comparing a measured pattern of impedance and spectral parameters at the sampling points to known impedance patterns and spectral parameters of normal and diseased organs, are used in establishing a diagnosis 316 and treatment plan.
  • the outer needle 106 is advanced to excise a sample.
  • the trocar 102 is then removed to transfer the sample to a pathology sample container and reinserted into the outer needle 106 before advancing the device to any additional sampling points.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Molecular Biology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pathology (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Animal Behavior & Ethology (AREA)
  • Surgery (AREA)
  • Physics & Mathematics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biophysics (AREA)
  • Radiology & Medical Imaging (AREA)
  • Measurement And Recording Of Electrical Phenomena And Electrical Characteristics Of The Living Body (AREA)
  • Surgical Instruments (AREA)

Abstract

L'invention porte sur un dispositif d'échantillonnage de biopsie qui comporte un trocart interne possédant un embout pointu et un orifice d'échantillonnage. Le trocart est mis en prise de façon coulissante dans une cavité centrale d'une aiguille externe avec son embout pointu et un orifice d'échantillonnage faisant saillie à partir d'une extrémité de l'aiguille externe. Un appareil de mesure d'impédance mesure l'impédance entre le trocart interne et l'aiguille externe. Dans un mode de réalisation, l'impédance est mesurée à de multiples fréquences et des caractéristiques spectrales sont déterminées à partir de celle-ci. Le trocart interne comporte un revêtement isolant sur les parties du trocart interne qui sont situées à l'intérieur de la cavité centrale de l'aiguille externe. Dans un mode de réalisation, le dispositif d'échantillonnage est utilisé pour obtenir des échantillons d'un organe en des points de l'organe où l'impédance diffère de l'impédance du stroma d'organe.
PCT/US2009/043181 2008-05-23 2009-05-07 Dispositif et procédé d'échantillonnage de biopsie par mesure d'une impédance électrique Ceased WO2009142918A2 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
US12/994,055 US20110105948A1 (en) 2008-05-23 2009-05-07 Electrical Impedance Sensing Biopsy Sampling Device And Method

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US5568508P 2008-05-23 2008-05-23
US61/055,685 2008-05-23

Publications (3)

Publication Number Publication Date
WO2009142918A2 true WO2009142918A2 (fr) 2009-11-26
WO2009142918A3 WO2009142918A3 (fr) 2010-02-11
WO2009142918A8 WO2009142918A8 (fr) 2010-04-01

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US (1) US20110105948A1 (fr)
WO (1) WO2009142918A2 (fr)

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2783624A1 (fr) * 2013-03-28 2014-10-01 Injeq Oy Capteur de bioimpédance, mandrine, canule et procédé de mesure de bioimpédance
WO2016198910A1 (fr) 2015-06-07 2016-12-15 Injeq Oy Aiguille de biopsie pour échantillonnage par biopsie, dispositif de biopsie, et procédés de fabrication d'aiguille de biopsie ou de dispositif de biopsie
WO2022266501A1 (fr) * 2021-06-18 2022-12-22 Bard Access Systems, Inc. Systèmes médicaux de détermination d'impédance
US11759268B2 (en) 2012-04-05 2023-09-19 C. R. Bard, Inc. Apparatus and methods relating to intravascular positioning of distal end of catheter
US12029539B2 (en) 2003-02-21 2024-07-09 3Dt Holdings, Llc Systems, devices, and methods for mapping organ profiles
US12343091B2 (en) 2012-04-05 2025-07-01 C. R. Bard, Inc. Apparatus and methods relating to intravascular positioning of distal end of catheter

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR101441518B1 (ko) * 2012-12-06 2014-09-17 광주과학기술원 실시간 병변조직 진단용 체내 삽입용 프로브 및 이의 전극 제조 방법
US20160081585A1 (en) * 2013-08-02 2016-03-24 The Trustees Of Dartmouth College Multiple-electrode electrical impedance sensing biopsy sampling device and method
US20150038872A1 (en) * 2013-08-02 2015-02-05 The Trustees Of Dartmouth College Multiple-electrode electrical impedance sensing biopsy sampling device and method
WO2015123350A2 (fr) * 2014-02-11 2015-08-20 Shifamed Holdings, Llc Procédés et dispositif pour intervention bronchique

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7236816B2 (en) * 1996-04-25 2007-06-26 Johns Hopkins University Biopsy and sampling needle antennas for magnetic resonance imaging-guided biopsies
US6540695B1 (en) * 1998-04-08 2003-04-01 Senorx, Inc. Biopsy anchor device with cutter
US6337994B1 (en) * 1998-04-30 2002-01-08 Johns Hopkins University Surgical needle probe for electrical impedance measurements
US6306132B1 (en) * 1999-06-17 2001-10-23 Vivant Medical Modular biopsy and microwave ablation needle delivery apparatus adapted to in situ assembly and method of use

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US12029539B2 (en) 2003-02-21 2024-07-09 3Dt Holdings, Llc Systems, devices, and methods for mapping organ profiles
US11759268B2 (en) 2012-04-05 2023-09-19 C. R. Bard, Inc. Apparatus and methods relating to intravascular positioning of distal end of catheter
US12343091B2 (en) 2012-04-05 2025-07-01 C. R. Bard, Inc. Apparatus and methods relating to intravascular positioning of distal end of catheter
EP2783624A1 (fr) * 2013-03-28 2014-10-01 Injeq Oy Capteur de bioimpédance, mandrine, canule et procédé de mesure de bioimpédance
US10687730B2 (en) 2013-03-28 2020-06-23 Injeq Oy Bioimpedance sensor, stylet, cannula and method for measuring bioimpedance
WO2016198910A1 (fr) 2015-06-07 2016-12-15 Injeq Oy Aiguille de biopsie pour échantillonnage par biopsie, dispositif de biopsie, et procédés de fabrication d'aiguille de biopsie ou de dispositif de biopsie
US10779804B2 (en) 2015-06-07 2020-09-22 Injeq Oy Biopsy needle for biopsy sampling, biopsy device, and methods of manufacturing a biopsy needle or a biopsy device
WO2022266501A1 (fr) * 2021-06-18 2022-12-22 Bard Access Systems, Inc. Systèmes médicaux de détermination d'impédance

Also Published As

Publication number Publication date
WO2009142918A8 (fr) 2010-04-01
WO2009142918A3 (fr) 2010-02-11
US20110105948A1 (en) 2011-05-05

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